Evonik

Evonik is one of the world’s leading CDMOs for advanced drug delivery. Our integrated portfolio of functional excipients, technologies and services for the formulation development, process scale-up and cGMP manufacturing of complex oral and parenteral drug products can reduce your project risk, boost performance and increase brand preference.

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For more than 60 years, Evonik has been a preferred global supplier of functional excipients for oral solid dosage forms and complex parenterals. EUDRAGIT® is the world’s leading portfolio of polymethacrylate-based coating systems for the immediate, delayed or sustained release and solubility enhancement of oral solid dosage forms. The new EUDRACAP™ platform of functional ready-to-fill capsules provides best-in-class functional performance and custom versatility for optimized release profiles and accelerated speed-to-market. With EUDRATEC® we have established an extensive portfolio of patent-protected and commercially feasible oral drug delivery technologies to overcome complex formulation challenges.

As one of the world’s leading CDMOs for complex parenteral drug products, our portfolio includes the market leading RESOMER® & LACTEL® portfolio of bioresorbable excipients, as well as CMO services for proprietary excipients. Evonik also offers lipids for injectable lipid nanoparticle (LNP) formulations including PhytoChol® vegetal-derived cholesterol & capabilities for custom manufactured lipids. CDMO services include the formulation & process development, GMP manufacturing & aseptic filling of drug products that utilize polymeric or lipid-based delivery technologies.

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Latest launches 

• EUDRACAP™ – The new platform of easy to handle capsules from Evonik
• EUDRATEC® Fasteric for enteric protection and rapid release in the upper small intestine
• EUDRAGIT® Ready-to-mix powders for immediate release
• EUDRAGIT® FL 30 D-55 – a new platinum standard for enteric coatings
• EUDRATEC® SoluFlow – Development and manufacturing solubility enhancement service for particle-engineered free-flowing amorphous solid dispersions

Our global network

Evonik operates a global network of trusted manufacturing sites, formulation and application labs and customer support centers across North and South America, Europe and the Asia-Pacific to ensure you receive reliable and responsive support.  At each of these sites, customers can leverage the strong, API, excipient, processing and manufacturing expertise of our teams to reduce project risk and optimize product performance.

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Our solutions

EUDRAGIT® functional polymers for oral drug delivery

EUDRAGIT® delivers unrivalled versatility to unlock the potential of APIs targeted for use with dosage forms including multiparticulates, tablets, capsules and films. Able to be used individually or in combination with other oral excipients or substances, EUDRAGIT®-based formulations can be precisely tuned to a range of common release profiles including immediate, delayed, sustained or customized release. A number of solutions are also available to enhance the solubility and bioavailability of oral solid dosage forms.

Immediate Release

• Functional excipients for:
  • Taste and odor masking, light and moisture protection
  • Swallowability enhancement
• Characterized by
  • Solubility in gastric fluid up to pH 5.0
  • Swelling and permeability above pH 5.0
  • Low viscosity
  • High pigment binding capacity
  • Excellent adhesion
  • High effectiveness in thin coatings
• EUDRAGIT® solutions include:
  • EUDRAGIT® E PO ReadyMix (Ready-to-use powder)
  • EUDRAGIT® IR ReadyMix White (Ready-to-use powder)
  • EUDRAGIT® E PO (Powder)
  • EUDRAGIT® E 100 (Granules)
  • EUDRAGIT® E 12,5 (Organic solution)

Delayed Release: Mid-upper small intestine

• Functional excipients
  • EUDRAGIT® FL 30 D-55 (Aqueous dispersion)
  • EUDRAGIT® L 30 D-55 (Aqueous dispersion)
  • EUDRAGIT® L 100 (Powder)
  • EUDRAGIT® L 100-55 (Powder)
  • EUDRAGIT® L 12,5 (Organic solution)
• Value-adding products
  • PlasACRYL® HTP20 (easy to use glidant and plasticizer premix)

Delayed Release: Colonic delivery

• Functional excipients
  • EUDRAGIT® S 100 (Powder)
  • EUDRAGIT® S 12,5 (Organic Solution)
  • EUDRAGIT® FS 30 D (Aqueous dispersion)
  • EUDRAGIT® FS 100 (Powder)
• Value-adding products
  • PlasACRYL® T20 (easy to use glidant and plasticizer premix)

Time-Controlled Release

• Functional excipients (insoluble, high permeability, independent swelling)
  • EUDRAGIT® RL PO (Powder)
  • EUDRAGIT® RL 100 (Granules)
  • EUDRAGIT® RL 30 D (Aqueous Dispersion)
  • EUDRAGIT® RL 12,5 (Organic Solution)
• Functional excipients (insoluble, low permeability, independent swelling)
  • EUDRAGIT® RS PO (Powder)
  • EUDRAGIT® RS 100 (Granules)
  • EUDRAGIT® RS 30 D (Aqueous Dispersion)
  • EUDRAGIT® RS 12,5 (Organic Solution)
• Functional excipients (insoluble, low permeability, Ph-independent swelling, no plasticizer)
  • EUDRAGIT^® NM 30 D (Aqueous Dispersion)

Solubility Enhancement

• For use with Amorphous Solid Dispersions (ASD) technologies to address:
  • Poor API solubility
  • Poor stability in the GIT
  • Low bioavailability
• EUDRAGIT® delivers strong performance as a carrier in ASD across all technologies
  • Immediate release for use with Hot Melt Extrusion and Spray Drying technologies
    • EUDRAGIT^® E 100 (Granules)
    • EUDRAGIT^® E PO (Powder)
    • EUDRAGIT^® L 100-55 (Powder)
    • EUDRAGIT^® L 100 (Powder)
  • Colon targeting for use with Hot Melt Extrusion and Spray Drying technologies
    • EUDRAGIT® FS 100 (Powder)

Cleaning Agents

• Chematic® FL Cleaner
• Chematic® L/S Plus Cleaner
• Chematic® NE/NM Cleaner
• Chematic® RL/RS Cleaner

EUDRACAP™ functional ready-to-fill capsules for oral drug delivery

• EUDRACAP™ enteric:​ Functional ready-to-fill capsules​ for release in upper small intestine

 

Advanced oral drug delivery technologies

Functional ready-to-fill capsules with customized release profile

• EUDRACAP™ – The new platform of easy to handle capsules from Evonik

Common application objectives

• Good absorption site for peptides / proteins
• Protection from hydrolyses
• Protection from enzymatic degradation
• Extended transit times
• Viscous environment can affect absorption
• Variability in disintegration time
• Avoid side effects under high doses

Drug delivery technologies for upper small intestine targeting

• EUDRATEC^® Fasteric (advanced bilayer technology) (PDF)

• • Increase gastric resistance and improve intestinal absorption for drug products
    targeting proximal region of small intestine where there is a narrow absorption window

Drug delivery technologies for colon targeting

• Phloral^® (Dual-action mechanism (pH and natural polysaccharide) (PDF)

• • Maintains integrity of coating upon arrival at colon
  • Applicable to all tablets, capsules, and multiparticulates

• DuoCoat^® (Double coating technology) (PDF)

• • Customizable for accelerated release in the colon
  • Based on approved EUDRAGIT^® polymers

Development and manufacturing service for solubility enhancement

EUDRATEC® SoluFlow – Solubility enhancement service for particle-engineered free-flowing amorphous solid dispersions

• Unique emulsion-based process based on standard pharma equipment to manufacture uniform microparticles with a controlled target particle size at high yield
• Soluble free-flowing amorphous solid dispersion intermediates that can easily be compressed to tablets or filled into capsules
• Development and manufacturing services of soluble intermediates from lab to commercial scale using mathematical scale-up models and online droplet size measurements

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onCare

Our online platform offers you all technical and regulatory support you need for your development. A huge variety of information and interactive tools is available anytime, anywhere, around the world.

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Brochures

EUDRAGIT® functional excipients

EUDRATEC® Fasteric for mid-to-upper small intestine targeting

PHLORAL® Factsheet

DuoCoat® Factsheet

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